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A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01046370
Collaborator
(none)
57
Enrollment
1
Location
2
Arms
19
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM).

CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A case series of 33 patients with CFS and ARP reported improvement in 92% of patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However ARP has never been formally studied in CFS.

We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will undergo standard clinical treatment which consist of a 2 day self-management program in the Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C group. The ARP group will receive an additional 2.5 hour training surrounding core concepts of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support. The C group will receive only standard care. However they will receive a complementary copy of the ARP program at the end of the study (6 month time point) as a gift for participation in the study.

Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36 (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of ARP and any specific difficulties they encountered in the practice of the program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Amygdala Retraining Program
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Amygdala Retraining Program (ARP) Versus Control (C) in Patients With Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM)
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARP intervention

Behavioral: Amygdala Retraining Program
Mind-body intervention.
No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

  1. chronic fatigue syndrome, chronic fatigue and fibromyalgia symptom severity [6 months]

Secondary Outcome Measures

  1. fatigue as assessed by Multidimensional Fatigue Inventory (MDFI) and Epworth Sleep Scale (ESS) [6 months]

  2. pain as assessed by the Fibromyalgia Impact Questionnaire (FIQ) and Measure Your Medical Outcome Profile (MYMOP-2) [6 months]

  3. quality of life as assessed by the Short Form-36 (SF-36) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • meet CDC criteria for Chronic Fatigue Syndrome, have been diagnosed with chronic fatigue, or meet the American College of Rheumatology criteria for fibromyalgia
Exclusion Criteria:

  • untreated hypo or hyper thyroidism

  • untreated hypo or hyper parathyroidism

  • untreated adrenal disorders

  • untreated diabetes

  • multiple sclerosis

  • acute or chronic hepatitis

  • history of cancer

  • untreated depression

  • chronic steroid use

  • acute inflammatory rheumatological conditions

  • untreated obstructive sleep apnea

  • narcolepsy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Ann Vincent, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ann Vincent, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01046370
Other Study ID Numbers:
  • 09-003509
First Posted:
Jan 12, 2010
Last Update Posted:
May 3, 2012
Last Verified:
May 1, 2012
Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Fatigue

Study Results

No Results Posted as of May 3, 2012